Manufacturers/Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC

165 drugs in NADAC|157 Generic,8 Brand

View Recalls (50)

Fresenius Kabi USA, LLC lists 165 NDCs in the CMS NADAC file (157 generic, 8 brand), at an average NADAC of $24.56 per unit, with a week-over-week move of -0.1% across products that moved. The firm's full portfolio, pricing trend, and FDA recalls are listed below.

Total Drugs

165

157G / 8B

Avg Price / Unit

$24.5645

$0.03 – $872.72

Avg 7d Change

-0.10%

Across 90 drugs with changes

7d Activity

41↑49↓75 flat

of 165 total drugs

Portfolio Price Trend

Monthly average NADAC price across all drugs

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Frequently Asked Questions

How many drugs does Fresenius Kabi USA, LLC make?

Fresenius Kabi USA, LLC lists 165 NDCs in the CMS NADAC file — 157 generic and 8 brand products.

What is the average price of Fresenius Kabi USA, LLC drugs?

The average NADAC across Fresenius Kabi USA, LLC's portfolio is $24.5645 per unit, ranging from $0.0273 to $872.7167.

What types of drugs does Fresenius Kabi USA, LLC make?

Fresenius Kabi USA, LLC makes drugs across 53 FDA pharmacologic classes. The most common by NDC count are Low Molecular Weight Heparin (25), Antidote (9), Antidote for Acetaminophen Overdose (9), Mucolytic (9), Corticosteroid (9).

Has Fresenius Kabi USA, LLC had any drug recalls?

50 FDA recalls are matched to Fresenius Kabi USA, LLC in the openFDA feed, most recently on Aug 10, 2026.

How has Fresenius Kabi USA, LLC's pricing changed recently?

Over the past 7 days, 41 Fresenius Kabi USA, LLC products rose and 49 fell, with a portfolio-wide average change of -0.1%.

Drug Portfolio

165 drugs total, 165 shown

Drug ↕Price 7d Change ↕
ADALIMUMAB-AACF(CF) PEN 40 MG/0.8 ML (2 PACK)
adalimumab
$872.7167
per EA
-0.01%
TYENNE 162 MG/0.9 ML AUTOINJCT
Tocilizumab-aazg
$820.9966
per ML
0.00%
TYENNE 162 MG/0.9 ML AUTOINJCT
Tocilizumab-aazg
$820.9966
per ML
0.00%
CHORIONIC GONAD 10,000 UNIT VL
Chorionic Gonadotropin
$253.0477
per EA
+0.58%
GLUCAGON 1 MG EMERGENCY KIT
Glucagon
$240.4042
per EA
+0.50%
GANIRELIX ACET 250 MCG/0.5 ML
Ganirelix Acetate
$62.3467
per ML
—
BORTEZOMIB 3.5 MG VIAL
Bortezomib
$43.3460
per EA
—
OCTREOTIDE 1,000 MCG/ML VIAL
OCTREOTIDE ACETATE
$41.7580
per ML
—
VANCOMYCIN HCL 5 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$39.3160
per EA
—
VANCOMYCIN HCL 5 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$39.3160
per EA
—
FOSAPREPITANT 150 MG VIAL
FOSAPREPITANT
$38.5080
per EA
—
VANCOMYCIN HCL 10 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$35.8586
per EA
—
VANCOMYCIN HCL 10 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$35.8586
per EA
—
VORICONAZOLE 200 MG VIAL
Voriconazole
$28.7741
per EA
—
ERTAPENEM 1 GRAM VIAL
Ertapenem Sodium
$26.6295
per EA
-4.06%
BLEOMYCIN SULFATE 15 UNIT VIAL
BLEOMYCIN SULFATE
$26.4480
per EA
—
DAPTOMYCIN 500 MG VIAL
Daptomycin
$20.7686
per EA
—
DAPTOMYCIN 500 MG VIAL
Daptomycin
$20.7686
per EA
—
GEMCITABINE HCL 1 GRAM VIAL
GEMCITABINE
$19.9960
per EA
—
GEMCITABINE HCL 1 GRAM VIAL
GEMCITABINE
$19.9960
per EA
—
DESMOPRESSIN 40 MCG/10 ML VIAL
Desmopressin Acetate
$19.1479
per ML
-6.33%
DESMOPRESSIN AC 4 MCG/ML VIAL
Desmopressin Acetate
$19.1479
per ML
-6.33%
HALOPERIDOL DEC 100 MG/ML VIAL
HALOPERIDOL DECANOATE
$16.1395
per ML
+0.77%
HALOPERIDOL DEC 100 MG/ML VIAL
HALOPERIDOL DECANOATE
$16.1395
per ML
+0.77%
HALOPERIDOL DEC 500 MG/5 ML VL
HALOPERIDOL DECANOATE
$15.5981
per ML
+8.90%
COLISTIMETHATE 150 MG VIAL
COLISTIMETHATE SODIUM
$15.4867
per EA
—
ENOXAPARIN 150 MG/ML SYRINGE
enoxaparin sodium
$15.3321
per ML
—
SUMATRIPTAN 6 MG/0.5 ML VIAL
Sumatriptan Succinate
$15.0000
per ML
—
ENOXAPARIN 120 MG/0.8 ML SYR
enoxaparin sodium
$14.8986
per ML
—
HALOPERIDOL DEC 50 MG/ML VIAL
HALOPERIDOL DECANOATE
$12.4667
per ML
—
FLUPHENAZINE DEC 125 MG/5 ML
FLUPHENAZINE DECANOATE
$10.8440
per ML
-0.44%
ENOXAPARIN 120 MG/0.8 ML SYR
Enoxaparin Sodium
$10.4173
per ML
-4.36%
ENOXAPARIN 300 MG/3 ML VIAL
enoxaparin sodium
$9.8724
per ML
-3.84%
ENOXAPARIN 40 MG/0.4 ML SYR
enoxaparin sodium
$9.8516
per ML
—
ENOXAPARIN 30 MG/0.3 ML SYR
enoxaparin sodium
$9.6878
per ML
—
ENOXAPARIN 80 MG/0.8 ML SYR
enoxaparin sodium
$9.3253
per ML
—
ENOXAPARIN 30 MG/0.3 ML SYR
Enoxaparin Sodium
$9.1268
per ML
-4.83%
ENOXAPARIN 30 MG/0.3 ML SYR
Enoxaparin Sodium
$9.1268
per ML
-4.83%
ENOXAPARIN 30 MG/0.3 ML SYR
enoxaparin sodium
$9.1268
per ML
-4.83%
ENOXAPARIN 150 MG/ML SYRINGE
Enoxaparin Sodium
$8.9038
per ML
-7.60%
ENOXAPARIN 40 MG/0.4 ML SYR
Enoxaparin Sodium
$7.7791
per ML
-4.26%
ENOXAPARIN 40 MG/0.4 ML SYR
enoxaparin sodium
$7.7791
per ML
-4.26%
ENOXAPARIN 40 MG/0.4 ML SYR
Enoxaparin Sodium
$7.7791
per ML
-4.26%
ENOXAPARIN 60 MG/0.6 ML SYR
enoxaparin sodium
$7.6220
per ML
—
HEPARIN SODIUM 20,000 UNIT/ML VIAL
HEPARIN SODIUM
$7.6218
per ML
—
ENOXAPARIN 60 MG/0.6 ML SYR
Enoxaparin Sodium
$7.4522
per ML
-2.23%
ENOXAPARIN 60 MG/0.6 ML SYR
Enoxaparin Sodium
$7.4522
per ML
-2.23%
ENOXAPARIN 60 MG/0.6 ML SYR
enoxaparin sodium
$7.4522
per ML
-2.23%
CEFAZOLIN 10 GM VIAL
Cefazolin Sodium
$7.2930
per EA
—
ENOXAPARIN 80 MG/0.8 ML SYR
Enoxaparin Sodium
$6.6868
per ML
-1.27%
ENOXAPARIN 80 MG/0.8 ML SYR
enoxaparin sodium
$6.6868
per ML
-1.27%
ENOXAPARIN 80 MG/0.8 ML SYR
Enoxaparin Sodium
$6.6868
per ML
-1.27%
ENOXAPARIN 100 MG/ML SYRINGE
enoxaparin sodium
$6.5933
per ML
—
ENOXAPARIN 100 MG/ML SYRINGE
enoxaparin sodium
$6.4517
per ML
-2.15%
ENOXAPARIN 100 MG/ML SYRINGE
Enoxaparin Sodium
$6.4517
per ML
-2.15%
ENOXAPARIN 100 MG/ML SYRINGE
Enoxaparin Sodium
$6.4517
per ML
-2.15%
ACETYLCYSTEINE 6 GRAM/30 ML VL
Acetylcysteine
$6.1376
per ML
—
HEPARIN SODIUM 5,000 UNIT/0.5 ML SYRINGE
Heparin Sodium
$5.8995
per ML
—
EPHEDRINE SULFATE 50 MG/ML VL
Ephedrine Sulfate
$5.6366
per ML
—
CEFEPIME HCL 2 GRAM VIAL
Cefepime
$5.3480
per EA
—
OCTREOTIDE 1,000 MCG/5 ML VIAL
OCTREOTIDE ACETATE
$5.3404
per ML
—
MEROPENEM IV 1 GM VIAL
Meropenem
$4.6875
per EA
+0.40%
MEROPENEM IV 1 GM VIAL
Meropenem
$4.6875
per EA
+0.40%
ZOLEDRONIC ACID 4 MG/5 ML VIAL
Zoledronic Acid
$4.6828
per ML
—
CEFEPIME HCL 1 GM VIAL
Cefepime
$3.7308
per EA
—
AZITHROMYCIN I.V. 500 MG VIAL
AZITHROMYCIN MONOHYDRATE
$3.5270
per EA
—
AZITHROMYCIN I.V. 500 MG VIAL
AZITHROMYCIN MONOHYDRATE
$3.5270
per EA
—
PIPERACIL-TAZOBACT 3.375 GM VL
Piperacillin and Tazobactam
$3.4926
per EA
—
PIPERACIL-TAZOBACT 3.375 GM VL
Piperacillin and Tazobactam
$3.4926
per EA
—
PIPERACIL-TAZOBACT 3.375 GM VL
Piperacillin and Tazobactam
$3.4926
per EA
—
HEPARIN SOD 5,000 UNIT/ML SYRG
Heparin Sodium
$3.3446
per ML
—
METHYLPREDNISOLONE SS 125 MG
METHYLPREDNISOLONE SODIUM SUCCINATE
$3.2655
per EA
-8.90%
AMPICILLIN 2 GM VIAL
ampicillin sodium
$3.2338
per EA
—
METHOTREXATE 250 MG/10 ML VIAL
METHOTREXATE SODIUM
$3.1832
per ML
+1.75%
MEROPENEM IV 500 MG VIAL
Meropenem
$2.8678
per EA
—
MEROPENEM IV 500 MG VIAL
Meropenem
$2.8678
per EA
—
HYDROMORPHONE 2 MG/ML VIAL
Hydromorphone Hydrochloride
$2.7403
per ML
—
HYDROMORPHONE 500 MG/50 ML VL
Hydromorphone Hydrochloride
$2.5663
per ML
—
HYDROMORPHONE 50 MG/5 ML VIAL
Hydromorphone Hydrochloride
$2.5663
per ML
—
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$2.5539
per ML
-2.48%
OCTREOTIDE ACET 100 MCG/ML VL
OCTREOTIDE ACETATE
$2.5346
per ML
+5.18%
OCTREOTIDE ACET 100 MCG/ML VL
OCTREOTIDE ACETATE
$2.5346
per ML
+5.18%
AMIKACIN SULF 500 MG/2 ML VIAL
Amikacin Sulfate
$2.3276
per ML
+1.33%
THIAMINE 200 MG/2 ML VIAL
THIAMINE HYDROCHLORIDE
$2.2468
per ML
+3.90%
THIAMINE 200 MG/2 ML VIAL
THIAMINE HYDROCHLORIDE
$2.2468
per ML
+3.90%
THIAMINE 200 MG/2 ML VIAL
THIAMINE HYDROCHLORIDE
$2.2468
per ML
+3.90%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$2.2455
per ML
+3.80%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$2.2455
per ML
+3.80%
LORAZEPAM 2 MG/ML VIAL
Lorazepam
$2.1715
per ML
+2.58%
HEPARIN SODIUM 10,000 UNIT/ML VIAL
HEPARIN SODIUM
$2.0940
per ML
-0.09%
HALOPERIDOL LAC 5 MG/ML VIAL
HALOPERIDOL LACTATE
$1.8983
per ML
—
PACLITAXEL 100 MG/16.7 ML VIAL
Paclitaxel
$1.8891
per ML
—
FENTANYL 100 MCG/2 ML VIAL
Fentanyl Citrate
$1.7864
per ML
+3.44%
FENTANYL 2,500 MCG/50 ML VIAL
Fentanyl Citrate
$1.7864
per ML
+3.44%
KETAMINE 500 MG/5 ML VIAL
ketamine hydrochloride
$1.7804
per ML
+15.34%
PACLITAXEL 300 MG/50 ML VIAL
Paclitaxel
$1.7700
per ML
—
GLYCOPYRROLATE 0.2 MG/ML VIAL
Glycopyrrolate
$1.5143
per ML
+2.28%
GLYCOPYRROLATE 0.2 MG/ML VIAL
Glycopyrrolate
$1.5143
per ML
+2.28%
GLYCOPYRROLATE 0.2 MG/ML VIAL
Glycopyrrolate
$1.5143
per ML
+2.28%
CYANOCOBALAMIN 1,000 MCG/ML VL
CYANOCOBALAMIN
$1.4739
per ML
-1.34%
CYANOCOBALAMIN 1,000 MCG/ML VL
CYANOCOBALAMIN
$1.4739
per ML
-1.34%
CEFTRIAXONE 1 GM VIAL
Ceftriaxone
$1.4434
per EA
+0.05%
PROGESTERONE 500 MG/10 ML VIAL
PROGESTERONE
$1.3605
per ML
-5.22%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$1.3184
per ML
—
GENTAMICIN 80 MG/2 ML VIAL
GENTAMICIN SULFATE
$1.3026
per ML
-4.04%
GENTAMICIN 80 MG/2 ML VIAL
GENTAMICIN SULFATE
$1.3026
per ML
-4.04%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1796
per ML
+0.66%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1796
per ML
+0.66%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1796
per ML
+0.66%
FLUMAZENIL 0.5 MG/5 ML VIAL
FLUMAZENIL
$1.1791
per ML
—
DEXAMETHASONE 10 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$1.1568
per ML
-10.52%
DEXAMETHASONE 10 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$1.1568
per ML
-10.52%
CEFAZOLIN 1 GM VIAL
CEFAZOLIN SODIUM
$1.0703
per EA
+3.91%
LIDOCAINE HCL 1% VIAL
LIDOCAINE HYDROCHLORIDE
$1.0206
per ML
—
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$1.0175
per ML
-2.61%
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$1.0175
per ML
-2.61%
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$1.0175
per ML
-2.61%
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.9656
per ML
—
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
—
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
—
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
—
GENTAMICIN 40 MG/ML VIAL
GENTAMICIN SULFATE
$0.9335
per ML
—
DIPHENHYDRAMINE 50 MG/ML VIAL
DIPHENHYDRAMINE HYDROCHLORIDE
$0.8980
per ML
-3.81%
DIPHENHYDRAMINE 50 MG/ML VIAL
DIPHENHYDRAMINE HYDROCHLORIDE
$0.8980
per ML
-3.81%
TOBRAMYCIN 80 MG/2 ML VIAL
TOBRAMYCIN SULFATE
$0.8315
per ML
+12.45%
HALOPERIDOL LAC 5 MG/ML VIAL
HALOPERIDOL LACTATE
$0.7820
per ML
-0.88%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.7371
per ML
-0.57%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.7371
per ML
-0.57%
DEXAMETHASONE 120 MG/30 ML VL
DEXAMETHASONE SODIUM PHOSPHATE
$0.6940
per ML
-0.04%
DEXAMETHASONE 4 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.6735
per ML
+0.24%
DEXAMETHASONE 4 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.6735
per ML
+0.24%
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.6356
per ML
+0.08%
KETAMINE 500 MG/10 ML VIAL
ketamine hydrochloride
$0.5563
per ML
-0.30%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.5524
per ML
+10.91%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.5524
per ML
+10.91%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.5524
per ML
+10.91%
DEXAMETHASONE 100 MG/10 ML VL
DEXAMETHASONE SODIUM PHOSPHATE
$0.5104
per ML
+1.23%
FUROSEMIDE 20 MG/2 ML VIAL
FUROSEMIDE
$0.4901
per ML
+6.18%
FUROSEMIDE 20 MG/2 ML VIAL
FUROSEMIDE
$0.4901
per ML
+6.18%
ZOLEDRONIC ACID 5 MG/100 ML
Zoledronic Acid
$0.4751
per ML
-0.48%
MIDAZOLAM HCL 50 MG/10 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.4500
per ML
—
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
—
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
—
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
—
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
—
TRANEXAMIC ACID 1,000 MG/10 ML
Tranexamic Acid
$0.3481
per ML
—
WATER FOR INJECTION VIAL
WATER
$0.3150
per ML
+2.41%
XYLOCAINE 1%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
$0.2721
per ML
—
XYLOCAINE 1%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
$0.2721
per ML
—
XYLOCAINE 2%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
$0.2655
per ML
—
FUROSEMIDE 40 MG/4 ML VIAL
FUROSEMIDE
$0.2525
per ML
-4.99%
FUROSEMIDE 40 MG/4 ML VIAL
FUROSEMIDE
$0.2525
per ML
-4.99%
DEXAMETHASONE 20 MG/5 ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.2381
per ML
—
DEXAMETHASONE 20 MG/5 ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.2381
per ML
—
MIDAZOLAM HCL 2 MG/2 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.2334
per ML
-0.38%
ONDANSETRON HCL 4 MG/2 ML VIAL
ONDANSETRON HYDROCHLORIDE
$0.1759
per ML
-0.69%
ONDANSETRON HCL 4 MG/2 ML VIAL
ONDANSETRON HYDROCHLORIDE
$0.1759
per ML
-0.69%
ONDANSETRON 40 MG/20 ML VIAL
ONDANSETRON HYDROCHLORIDE
$0.1730
per ML
+1.77%
SODIUM BICARBONATE 8.4% VIAL
Sodium Bicarbonate
$0.1540
per ML
—
LIDOCAINE HCL 1% VIAL
LIDOCAINE HYDROCHLORIDE
$0.1378
per ML
—
SENSORCAINE 0.5% VIAL
BUPIVACAINE HYDROCHLORIDE
$0.0977
per ML
—
SODIUM CHLORIDE 0.9% VIAL
SODIUM CHLORIDE
$0.0887
per ML
+0.48%
WATER FOR INJECTION VIAL
WATER
$0.0661
per ML
—
SODIUM CHLORIDE 0.9% VIAL
SODIUM CHLORIDE
$0.0584
per ML
—
BACTERIOSTATIC SALINE VIAL
SODIUM CHLORIDE
$0.0273
per ML
—

FDA Recalls (50)

Recalls matched by company name. Verify current status with FDA.

D-0827-2026 →
Ongoing
Class I

Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Initiated: 8/10/2026
D-0788-2026 →
Ongoing
Class I

Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Initiated: 8/4/2026
D-0729-2026 →
Ongoing
Class II

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03

Presence of Particulate Matter: Hair was found in products

Initiated: 7/16/2026
D-0726-2026 →
Ongoing
Class II

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01

Presence of Particulate Matter: Hair was found in products

Initiated: 7/16/2026
D-0725-2026 →
Ongoing
Class II

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07

Presence of Particulate Matter: Hair was found in product

Initiated: 7/16/2026
D-0728-2026 →
Ongoing
Class II

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01

Presence of Particulate Matter: Hair was found in products

Initiated: 7/16/2026
D-0727-2026 →
Ongoing
Class II

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Presence of Particulate Matter: Hair was found in products

Initiated: 7/16/2026
D-0581-2026 →
Ongoing
Class III

Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)

Failed Impurities/Degradations Specifications

Initiated: 5/14/2026
D-0429-2026 →
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0431-2026 →
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0425-2026 →
Ongoing
Class II

0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0433-2026 →
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0436-2026 →
Ongoing
Class II

5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0437-2026 →
Ongoing
Class II

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0435-2026 →
Ongoing
Class II

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0430-2026 →
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0428-2026 →
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0426-2026 →
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0432-2026 →
Ongoing
Class II

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0424-2026 →
Ongoing
Class II

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0427-2026 →
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0434-2026 →
Ongoing
Class II

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0182-2026 →
Ongoing
Class I

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Initiated: 11/6/2025
D-0128-2023 →
Terminated
Class II

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Initiated: 11/22/2022
D-0129-2023 →
Terminated
Class II

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Initiated: 11/22/2022
D-0127-2023 →
Terminated
Class II

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Initiated: 11/22/2022
D-0750-2022 →
Terminated
Class I

Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

Initiated: 3/4/2022
D-0245-2021 →
Terminated
Class I

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 12/23/2020
D-0184-2021 →
Terminated
Class II

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 12/17/2020
D-0172-2021 →
Terminated
Class II

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Low out-of-specification assay results for the epinephrine component.

Initiated: 12/10/2020
D-0120-2021 →
Terminated
Class I

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05

Cross Contamination with other products: trace amounts of lidocaine

Initiated: 11/17/2020
D-0105-2021 →
Terminated
Class III

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05

Cross Contamination with Other Products: trace amounts of octreotide found during testing

Initiated: 11/17/2020
D-1537-2020 →
Terminated
Class I

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05

Cross Contamination with other products: trace amounts of lidocaine

Initiated: 7/22/2020
D-1391-2020 →
Terminated
Class III

Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10

Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.

Initiated: 7/13/2020
D-1296-2020 →
Terminated
Class I

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 4/20/2020
D-1297-2020 →
Terminated
Class II

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 4/20/2020
D-1489-2019 →
Terminated
Class I

Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]

Presence of Particulate Matter; glass particulates

Initiated: 6/28/2019
D-1386-2019 →
Terminated
Class III

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

Failed Impurities/Degradation Specifications.

Initiated: 5/22/2019
D-0298-2019 →
Terminated
Class I

SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610

Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.

Initiated: 11/15/2018
D-0299-2019 →
Terminated
Class I

SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620

Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.

Initiated: 11/15/2018
D-0426-2018 →
Terminated
Class III

Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10

Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.

Initiated: 1/16/2018
D-0152-2018 →
Terminated
Class I

Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20

Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL

Initiated: 10/27/2017
D-0647-2017 →
Terminated
Class III

Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05

Subpotent Drug

Initiated: 3/16/2017
D-0456-2017 →
Terminated
Class II

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05

Failed Impurities/Degradation Specifications

Initiated: 12/16/2016
D-0867-2016 →
Terminated
Class II

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04

Failed Impuities/Degradation Specifications

Initiated: 5/4/2016
D-0866-2016 →
Terminated
Class II

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.

Failed Impuities/Degradation Specifications

Initiated: 5/4/2016
D-1037-2016 →
Terminated
Class II

Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37

Presence of Particulate Matter: Glass particulate found in sterile injectable product

Initiated: 4/25/2016
D-0818-2016 →
Terminated
Class III

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

Initiated: 4/7/2016
D-0819-2016 →
Terminated
Class II

Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10

Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.

Initiated: 4/5/2016
D-1327-2015 →
Terminated
Class III

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

Initiated: 7/28/2015